FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
80689–80712 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 12, 2000
OPUS 20, MODEL 1ST
K002899 · GEX
Opusdent , Ltd.
General & Plastic Surgery · 85d
Cleared Dec 12, 2000
SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901
K002970 · JXG
Medical Designs, LLC
Neurology · 81d
Cleared Dec 12, 2000
STEALTHSTATION TREATMENT GUIDANCE PLATFORM
K003201 · HAW
Medtronic Surgical Navigation...
Neurology · 61d
Cleared Dec 12, 2000
PST ELECTROSURGICAL GENERATOR, MODEL 2150, PST BIPOLAR FORCEPS, MODEL EBF 1228
K003249 · GEI
Pst, Inc.
General & Plastic Surgery · 56d
Cleared Dec 12, 2000
COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP
K003616 · FRN
Baxter Healthcare Corp
General Hospital · 20d
Cleared Dec 12, 2000
LEIBINGER NEURO CLIP SYSTEM
K003660 · JEY
Stryker Instruments
Dental · 14d
Cleared Dec 11, 2000
SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-100
K000249 · FIP
Schaefer Water Centers
Gastroenterology & Urology · 319d
Cleared Dec 11, 2000
PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR
K000851 · DJG
Psychemedics Corp.
Toxicology · 271d
Cleared Dec 11, 2000
VERSABOND BONE CEMENT
K001160 · LOD
Smith & Nephew, Inc.
Orthopedic · 245d
Cleared Dec 11, 2000
EBT ULTRAFAST CT SCANNER SYSTEM
K001550 · LLZ
Imatron, Inc.
Radiology · 207d
Cleared Dec 11, 2000
TRIDENT ALL POLY CUP
K001956 · JDI
Howmedica Osteonics Corp.
Orthopedic · 167d
Cleared Dec 11, 2000
MODEL 30 CLASSIC PNEUMATONOMETER
K002395 · HKX
Xomed, Inc.
Ophthalmic · 126d
Cleared Dec 11, 2000
ELECTRIC MOBILITY RASCAL AND CHAUFFER SCOOTERS
K002616 · INI
Electric Mobility Corp.
Physical Medicine · 111d
Cleared Dec 11, 2000
TRILOGY ACETABULAR SYSTEM LARGE HEAD LINER, MODEL 6353
K002960 · LPH
Zimmer, Inc.
Orthopedic · 80d
Cleared Dec 11, 2000
SYNERGY HA COATED POROUS FEMORAL STEMS
K002996 · MEH
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared Dec 11, 2000
MERIT DRAINAGE DEPOT
K003078 · EXF
Merit Medical Systems, Inc.
Gastroenterology & Urology · 69d
Cleared Dec 11, 2000
MILLENNIUM BLADES, MODEL MB101
K003143 · HNO
Millennium Biomedical, Inc.
Ophthalmic · 62d
Cleared Dec 11, 2000
EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP
K994146 · LWJ
Plus Orthopedics
Orthopedic · 369d
Cleared Dec 10, 2000
SNARE,FLEXIBLE
K002927 · FDI
Odon Lifetechnology
Gastroenterology & Urology · 81d
Cleared Dec 08, 2000
LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE
K000594 · JEY
Stryker Leibinger
Dental · 290d
Cleared Dec 08, 2000
HANGER CRANIAL BAND
K001669 · MVA
Hanger Orthopedic Group, Inc.
Neurology · 191d
Cleared Dec 08, 2000
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
K001895 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 170d
Cleared Dec 08, 2000
NOVOFINE 31 DISPOSABLE NEEDLE
K002403 · FMI
Novo Norodisk Pharmaceuticals, Inc.
General Hospital · 123d
Cleared Dec 08, 2000
ADVENT IMPLANT SYSTEM
K002614 · DZE
Core-Vent Corp.
Dental · 108d